1.1 ,This guide identifies important factors to consider when selecting a disinfectant for use in a cleanroom or similar controlled environment and recommends test methods suitable for evaluating disinfectants. The proper selection of disinfecting agent combined with qualification testing is a key element of a successful disinfection program. Regulatory guidance such as United States Pharmacopoeia Chapter <,1072>,, “,Disinfectants and Antiseptics”, and the FDA Guidance for Industry, “,Sterile Drug Products Produced by Aseptic Processing–,Current Good Manufacturing Practice”, address the necessity of disinfectant effectiveness testing but do not clearly define acceptable test methods.